Baseline characteristics of TICH-2 participants by prerandomisation baseline SBP
All | SBP≤170 mm Hg | SBP>170 mm Hg | P value | |
No of patients | 2325 | 1152 | 1173 | |
Age (years) | 68.9 (13.8) | 70 (13.2) | 67.8 (14.3) | <0.001 |
>70 | 1164 (50.1) | 620 (53.8) | 544 (46.4) | <0.001 |
Sex, male (%) | 1301 (56) | 670 (58.2) | 631 (53.8) | 0.034 |
Baseline mRS [/6] | 0 [0, 1] | 0 [0, 1] | 0 [0, 1] | 0.057 |
Medical history (%) | ||||
Hypertension | 1421 (61.1) | 652 (56.6) | 769 (65.6) | <0.001 |
Diabetes mellitus | 312 (13.4) | 156 (13.5) | 156 (13.3) | 0.72 |
Atrial fibrillation | 71 (3.1) | 41 (3.6) | 30 (2.6) | 0.37 |
Previous stroke/TIA | 329 (14.2) | 182 (15.8) | 147 (12.5) | 0.049 |
Previous ICH | 126 (5.4) | 84 (7.3) | 42 (3.6) | <0.001 |
Ischaemic heart disease | 202 (8.7) | 102 (8.9) | 100 (8.5) | 0.78 |
Antiplatelet therapy | 611 (26.3) | 336 (29.2) | 275 (23.4) | 0.005 |
Statin therapy | 622 (26.8) | 348 (30.2) | 274 (23.4) | 0.001 |
Qualifying event | ||||
NIHSS [/42] | 12 [7,19] | 12 [6,19] | 13 [7,18] | 0.27 |
GCS [/15] | 15 [12,15] | 15 [12,15] | 14 [12,15] | 0.65 |
Haemodynamics | ||||
BP, systolic (mm Hg) [range] | 172.6 (27.1) [98–265] | 150.8 (14.3) [98–170] | 194 (18.3) [171–265] | <0.001 |
BP, diastolic (mm Hg) [range] | 93.2 (18.1) [36–179] | 84.1 (13.6) [36–152] | 102.1 (17.5) [55–179] | <0.001 |
Randomisation to tranexamic acid (%) | 1161 (49.9) | 590 (51.2) | 571 (48.7) | 0.22 |
Time to randomisation [hours] | 3.6 [2.6,5] | 3.9 [2.8,5.4] | 3.4 [2.5,4.7] | <0.001 |
<3 (%) | 833 (35.8) | 352 (30.6) | 481 (41) | <0.001 |
<4.5 (%) | 1575 (67.7) | 726 (63) | 849 (72.4) | <0.001 |
Haematoma location (%) | <0.001 | |||
Supratentorial lobar | 738 (31.7) | 447 (38.8) | 291 (24.8) | |
Supratentorial deep | 1371 (59) | 607 (52.7) | 764 (65.1) | |
Infratentorial | 149 (6.4) | 65 (5.6) | 84 (7.2) | |
Combination | 67 (2.9) | 33 (2.9) | 34 (2.9) | |
Haematoma volume (mL) [IQR] | 13.3 [5.5–32.3] | 14.1 [5.7–36.3] | 12.5 [5.3–29.5] | 0.032 |
Intraventricular haemorrhage (%) | 745 (32) | 341 (29.6) | 404 (34.4) | 0.012 |
CT angiography done (%) | 249 (10.7) | 129 (11.2) | 120 (10.2) | 0.031 |
Spot sign positive | 56 (2.4) | 21 (1.8) | 35 (3) | 0.039 |
Data are number (%), mean (SD), median [IQR], [range]; comparison across BP by χ2 test, Kruskal-Wallis test or one-way ANOVA.
ANOVA, analysis of variance; BP, blood pressure; GCS, Glasgow Coma Score; ICH, intracerebral haemorrhage; mRS, modified Rankin Scale; NIHSS, National Institutes for Health Stroke Scale; SBP, systolic BP; TIA, transient ischaemic attack; TICH-2, tranexamic acid for hyperacute spontaneous intracerebral haemorrhage-2.